(158 days)
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
The SYNTHES Spine Pediatric Rod System consists of rods. clamps and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295). The rod is provided in four lengths, 80, 120, 240 and 300mm. The rod diameter is 3.5mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw. a 4.0mm cancellous screw. or a 4.0mm or 4.35mm cxpansion screw with 1.8mm locking screw.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study data where available.
This submission describes a device equivalency claim rather than a study against a pre-defined set of acceptance criteria. The SYNTHES Spine Pediatric Rod System is compared to a predicate device (Acromed ISOLA Pediatric Components, K962984) to establish substantial equivalence, meaning it's assumed to be as safe and effective as the already-marketed predicate. Therefore, many of the typical study-related questions (like sample size, experts for ground truth, etc.) are not directly applicable in the same way they would be for a de novo device performance validation study.
Acceptance Criteria and Reported Device Performance
For this 510(k) submission, there are no explicit numerical acceptance criteria as would be found in a performance study trying to validate a new device against a benchmark. Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Justification |
|---|---|
| Intended Use: Device for grade 3 or 4 spondylolisthesis at L5-S1 vertebral joint, utilizing autologous bone graft, to be removed after solid fusion, for pediatric patients ≤ 50lbs. | Stated Identical Indications for Use: The SYNTHES Spine Pediatric Rod System is described with the same indications for use as the predicate (Acromed ISOLA Pediatric Components). The FDA's acceptance letter reiterates these specific, limited indications. |
| Technological Characteristics: Similar design principle (rods, clamps, screws), materials, and dimensions to the predicate. | Description of Device: The device consists of rods (3.5mm diameter, 4 lengths), clamps, and screws (3.5mm cancellous, 4.0mm cancellous, 4.0mm or 4.35mm expansion with 1.8mm locking screw). Materials are commercially pure grade 4 Titanium (screws) and titanium alloy TAN (clamps and rods). This aligns with the expectation of similarity to existing pedicle screw systems. |
| Performance (e.g., mechanical strength, biomechanical stability, biocompatibility): Adequate for the intended use and equivalent to the predicate device. | Implied by Substantial Equivalence: While no specific test results are provided in this summary, a 510(k) typically includes non-clinical performance data (e.g., mechanical testing, materials testing) to demonstrate that the new device performs as safely and effectively as the predicate for its intended use. The FDA's acceptance implies that these data were satisfactory. |
| Sterile Status: Provided non-sterile with recommended sterilization method. | Non-Sterile: Device is provided non-sterile; moist heat sterilization is recommended. This is a common characteristic for many implantable devices. |
Study Information (Based on 510(k) Equivalence)
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Sample size used for the test set and the data provenance:
- N/A. This 510(k) is a claim of substantial equivalence to an existing device (predicate) rather than a clinical study with a test set of patients or data samples. The "data" provided would typically be engineering specifications, material properties, and mechanical test results (non-clinical). Clinical data, if any, would likely be for the predicate device, not a specific "test set" for the SYNTHES device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth, in the context of clinical outcomes, is not directly established for this 510(k) submission on a "test set." The evaluation is regulatory, comparing the new device's features and performance data (usually non-clinical mechanical or material tests) to known predicate device characteristics.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This is not a clinical efficacy or performance study involving human readers or adjudicated outcomes.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a medical device (spinal implant) 510(k) submission, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. See point 4.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this 510(k) submission, the "ground truth" for the device's acceptable performance is largely derived from:
- Predicate device's established safety and effectiveness: The FDA has previously cleared the Acromed ISOLA Pediatric Components (K962984).
- Engineering and materials standards: Compliance with ASTM standards for Titanium (F67, F1295) indicates material suitability.
- Non-clinical performance data: Typically, mechanical bench testing (e.g., fatigue, static strength) is submitted in a 510(k) dossier to show the device meets or exceeds the performance of the predicate. This data serves as the "ground truth" for its mechanical properties.
- N/A. For this 510(k) submission, the "ground truth" for the device's acceptable performance is largely derived from:
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The sample size for the training set:
- N/A. There isn't a "training set" in the context of this device's regulatory pathway. Design and engineering would rely on engineering principles, material science, and the existing knowledge base for spinal implants.
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How the ground truth for the training set was established:
- N/A. See point 7.
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Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301
ﺴﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ
(610) 647-9700 Contact: Barry E. Sands 2/19/1998
Device: SYNTHES Spine Pediatric Rod System compared to the Acromed ISOLA Pediatic Components (K962984).
The SYNTHES Spine Pediatic Rod System consists of rods. clamps and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295).
The rod is provided in four lengths, 80, 120, 240 and 300mm. The rod diameter is 3.5mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw. a 4.0mm cancellous screw. or a 4.0mm or 4.35mm cxpansion screw with 1.8mm locking screw.
The device functions as follows: The end of the rod, cut to an appropriate leagth, is inscried into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
The SYNTHES Spine Pediatic Rod System is a pedicle screw fixation system for use in grade 3 or 4 spondylolisthesis at the fifth lumber - first sactal verrebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The STNTHES Spine Podiative Rod System is intended for pediatric patients with a body weight of 501bs or less.
This system is provided non-sterile; moist heat sterilization is recommended.
Based on the above, the SYNTHES Spine Pediativ Rod System is substantially coulvalcal to the Acromed ISOLA Pediatric Components.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Mr. Barry E. Sands Manager, Regulatory Affairs SYNTHES Spine P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
K980761 Re : SYNTHES Spine Pediatric Rod System Regulatory Class: Unclassified Product Code: MNH June 9, 1998 Dated: Received: June 10, 1998
Dear Mr. Sands:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act). found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than
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severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device . system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- . The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
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See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be reguired.
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Page 4 - Mr. Barry E. Sands
This letter will allow you to begin marketing your device as mis feecer wirr allow your begin maification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ----
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Page 1 of 1
510(k) Number (if known): NA K98 076 l
Device Name: SYNTHES Spine Pediatric Rod System
Indications for Use:
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 which labered for podicts berew interest sacral vertebral joint (LS-S1) utilizing autologous bone graft and spondytonsticsla at also multion - interestained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use _ OR Prescription Use (Per 21 CFR 801.109) (Divisir . Divisio 510(k) Number
N/A